公司报告 | 半年报点评 君实生物（688180） 证券研究报告 2025H1 特瑞普利单抗销售稳健增长，PD-1/VEGF 双抗进入 II 期临床 事件 公司于近日发布 2025 年半年报，2025H1，公司收入为 11.68 亿元，同比增 长 48.64%，净亏损为 4.13 亿元，同比减亏 36.01%，扣非净亏损为 4.78 亿 元，同比减亏 23.72%。 特瑞普利单抗 4 项适应症迎来医保元年，并新增获批 2 项新适应症 2025H1，特瑞普利单抗国内市场销售收入约 9.54 亿元，同比增长约 42%， 目前在国内共获批 12 项适应症，2025 年新增获批肝细胞癌 1L 和黑色素瘤 1L，还有联合维迪西妥单抗治疗 HER2+尿路上皮癌的 sNDA 获得 NMPA 受 理 。特瑞普利单抗目前共有 10 项适应症纳入医保目录，2025 年为其中 4 项新增纳入适应症的医保元年，分别为 NSCLC 辅助治疗、肾细胞癌 1L、 ES-SCLC 1L 和 PD-L1 阳性 TNBC 1L，覆盖人群较广。 在国际化布局方面，公司已和利奥制药等合作伙伴在欧盟、英国等超过 80 个国家达成商业化合作，已在美国、 ...

"调节性T细胞"及相关免疫疗法有望得到更多临床应用与转化 "调节性T细胞"及相关免疫疗法有望得到更多临床应用与转化。 当地时间10月6日，瑞典卡罗琳医学院宣布，将2025年诺贝尔生理学或医学奖授予（Mary E. Brunkow）、弗雷德·拉姆斯德尔（Fred Ramsdell）和坂口西蒙（Shimon Sakaguchi），以表彰他们"在外 周免疫耐受方面的发现"。 评选委员会认为，他们鉴定出免疫系统的"保镖"——调节性T细胞（下称"Tregs"），从而为一个全新的 研究领域奠定了基础。这些发现也促进了潜在疗法的开发，目前这些疗法正在临床试验中进行评估。人 们希望这一发现有助于治疗或治愈自身免疫性疾病，为癌症提供更有效的治疗，以及预防干细胞移植后 的严重并发症。 "三位科学家的研究，揭示了免疫系统自我约束的关键环节，他们的研究告诉我们：人类免疫系统的强 大不在于攻击，而在于克制。"一位免疫疗法研发领域人士告诉第一财经，Tregs是一种免疫负调节细 胞，其功能缺失或数量减少与Ⅰ型糖尿病、类风湿性关节炎、系统性红斑狼疮等密切相关，该领域研究 能给上述疑难、复杂疾病的病理机制研究提供理论支撑。该人士也称，另有研究 ...

October 3, 2025 Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Extraordinary General Meeting of shareholders will be held at 14:00 CET on Tuesday, November 18, 2025 at the offices of Freshfields LLP (Netherlands), Strawinskylaan 10, 1077 XZ Amsterdam, the Netherlands.The shareholders and all other persons with meeting rights are invited to attend the E ...

Summary of Alpha Tau Medical Conference Call Company Overview - **Company**: Alpha Tau Medical Ltd. (Ticker: DRTS) - **Industry**: Medical Technology, specifically focused on cancer treatment using alpha radiation Core Points and Arguments 1. **Unique Treatment Method**: Alpha Tau Medical is pioneering the use of alpha radiation directly applied to cancerous tumors, which is more efficient and effective than traditional gamma and beta radiation methods [2][4] 2. **Broad Applicability**: The treatment has shown effectiveness across approximately 20 tumor types in animal studies, with no tumors identified that do not respond [3] 3. **Immune System Activation**: The treatment not only destroys tumors but also appears to stimulate the immune system to recognize and combat tumors elsewhere in the body [3][19] 4. **FDA Engagement**: The company is in active dialogue with the FDA and is targeting large markets with a robust pipeline of upcoming milestones [4][35] 5. **Pivotal Trials**: The pivotal trial for recurrent cutaneous squamous cell carcinoma (SCC) is expected to complete patient recruitment by the end of the year, with data submission anticipated by mid-2026 [17][35] 6. **Pancreatic Cancer Program**: The company recently announced the first treatment in the U.S. for pancreatic cancer, with a focus on achieving a high disease control rate [5][29] 7. **Clinical Success**: In a pilot study for skin cancer, Alpha Tau achieved a 100% complete response rate, with no serious adverse events reported [16][17] 8. **Market Potential**: The Skin Cancer Foundation estimates 1.8 million new cutaneous SCC cases annually in the U.S., with about 64,000 cases being recurrent and difficult to treat [18] 9. **Combination with Immunotherapy**: Initial studies suggest that combining Alpha Tau's treatment with immunotherapy (e.g., Keytruda) may enhance overall response rates [21][25] 10. **Survival Benefits**: Early data indicates that patients treated with Alpha Tau's method may experience longer survival times compared to historical data for standard treatments [30][31] Additional Important Content 1. **Manufacturing Expansion**: Alpha Tau is building a commercial-scale facility in New Hampshire, aiming for a capacity of approximately 15,000 patients per year [36] 2. **Financial Health**: The company reported $83 million in cash and deposits as of Q2, with a consistent burn rate of about $5 million per quarter [37] 3. **Focus on High Unmet Need**: The company is exploring treatments for high unmet need cancers, including pancreatic cancer and glioblastoma, with ongoing trials [28][34] 4. **Regulatory Approvals**: Alpha Tau has received IDE approval from the FDA to start a U.S. study in glioblastoma, with patient recruitment expected to begin soon [34] This summary encapsulates the key points discussed during the conference call, highlighting Alpha Tau Medical's innovative approach to cancer treatment, its clinical successes, and its strategic focus on expanding its market presence and product pipeline.

Core Viewpoint - Immunotherapy, particularly immune checkpoint blockade (ICB), presents transformative potential for treating various malignancies, but challenges such as acquired resistance and immune-related adverse events (irAEs) persist, necessitating a dual approach to address both thromboembolic risks and treatment resistance [2][5]. Group 1: Research Findings - A study published in Cell Reports Medicine indicates that the antiplatelet drug Vorapaxar enhances mitochondria-associated ferroptosis, thereby improving cancer immunotherapy outcomes by targeting the FOXO1/HMOX1 axis [3][6]. - Vorapaxar, approved by the FDA in 2014, reversibly inhibits the PAR-1 receptor on platelets, blocking thrombin-mediated platelet activation, which is crucial for antithrombotic therapy [6]. - The study confirms that Vorapaxar binds to FOXO1, inhibiting its phosphorylation and promoting its nuclear translocation, leading to increased expression of heme oxygenase-1 (HMOX1) and subsequent mitochondrial iron overload and ferroptosis [6]. Group 2: Clinical Implications - Vorapaxar has been shown to enhance immune therapy-induced tumor ferroptosis and antitumor immunity in various melanoma mouse models, suggesting its potential as a powerful adjunct in immunotherapy [6][8]. - High co-expression of FOXO1/HMOX1 is associated with improved responses to immunotherapy and prolonged progression-free survival, indicating a promising biomarker for treatment efficacy [6][8]. - Overall, Vorapaxar is positioned as a dual-benefit solution for cancer patients requiring both thrombolytic and immunotherapeutic interventions, addressing the dual challenges of thromboembolism and treatment resistance [8].

Core Viewpoint - China Biologic Products (01177) announced that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has successfully completed the first patient enrollment in the Phase I clinical trial of its self-developed innovative drug LM-2417, a NaPi2b/4-1BB bispecific antibody, marking the entry of this innovative therapy into clinical development [1][2] Group 1 - LM-2417 is developed based on Lixin Pharmaceutical's self-researched conditionally activated 4-1BB platform, specifically binding to NaPi2b on tumor cells and 4-1BB on immune cells, enhancing anti-tumor effects through precise activation of immune cells in the tumor microenvironment [2] - NaPi2b is encoded by the SLC34A2 gene and is highly expressed in various malignancies, including high-grade serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer, thyroid cancer, breast cancer, and non-squamous non-small cell lung cancer, while having limited distribution in normal tissues, making it a promising target for anti-tumor therapy [1][2] - Preclinical data indicate that LM-2417 can induce durable anti-tumor immune memory and shows significant synergistic effects when combined with other immunotherapy drugs, positioning it as a potential First-in-Class immunotherapy [2] Group 2 - The clinical study is an open-label, dose-escalation, and dose-expansion Phase I/II trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of LM-2417 as a monotherapy or in combination with other anti-tumor drugs in patients with advanced malignant solid tumors [2] - The company aims to rapidly advance the clinical research of this project, looking forward to providing new options for immunotherapy clinical use for patients [2]

Core Viewpoint - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has successfully completed the first patient enrollment in the Phase I clinical trial of its innovative drug LM-2417, marking the entry of this therapy into clinical development [1][2]. Group 1: Product Development - LM-2417 is a dual-specific antibody targeting NaPi2b and 4-1BB, developed using Lixin Pharmaceutical's proprietary conditionally activated 4-1BB platform [2]. - The mechanism of LM-2417 allows for precise activation of immune cells in the tumor microenvironment, enhancing anti-tumor effects while potentially reducing non-specific immune activation toxicity [2]. - Preclinical data indicate that LM-2417 can induce durable anti-tumor immune memory and shows significant synergistic effects when combined with other immunotherapy drugs [2]. Group 2: Clinical Research - The ongoing clinical study is an open-label, dose-escalation, and dose-expansion Phase I/II trial assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of LM-2417 as a monotherapy or in combination with other anti-tumor drugs in patients with advanced malignant solid tumors [2]. - The company aims to expedite the clinical research process to provide new immunotherapy options for patients [2].

Core Insights - Immutep Limited has initiated a Phase II trial for neoadjuvant eftilagimod alfa (efti) in early-stage HR+/HER2-negative breast cancer patients, evaluating its use as a monotherapy and in combination with standard chemotherapy prior to surgery [1][4] Group 1: Trial Details - The study will involve up to 50 evaluable patients and is primarily funded by grants from The George Washington University Cancer Center, with Immutep providing efti at no cost and limited funding [2] - The trial is a single-arm interventional study focusing on the pathological complete response (pCR) after treatment with efti and neoadjuvant chemotherapy [4] - Patients will receive efti monotherapy for three weeks before starting chemotherapy in combination with efti [4] Group 2: Efti Mechanism and Benefits - Efti is a proprietary soluble LAG-3 protein that stimulates both innate and adaptive immunity, leading to the activation of various immune cells, including CD8+ T cells and dendritic cells [5][6] - The unique mechanism of efti may result in high rates of pathologic complete responses and improved disease-free survival in patients with stronger immune systems [3][4] Group 3: Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 [8] - The company aims to expand its clinical pipeline for neoadjuvant efti in areas of high unmet need, reflecting its commitment to innovative treatment options [4][8]

Core Viewpoint - Immunotherapy, particularly immune checkpoint blockade (ICB), has transformed cancer treatment but remains ineffective in "cold tumors" due to immune suppression in the tumor microenvironment (TME) [2][5][6] Group 1: Research Findings - A new biomimetic Ru/TiO₂ nanobiocatalyst system inspired by natural enzyme reaction systems (ERS) has been developed, capable of rapid, pH-dependent generation of reactive oxygen species (ROS) and oxygen (O₂), effectively converting cold tumors into hot tumors [3][6][7] - The Ru/TiO₂ system enhances anti-tumor immunity and suppresses tumor metastasis when used in conjunction with ICB therapy [3][7] - This research establishes a precedent for adaptive nanobiocatalysts in the TME and paves the way for the development of next-generation immunotherapies targeting drug-resistant cancers [3][6] Group 2: Mechanism of Action - The study demonstrates that Ru/TiO₂ can mediate immunogenic cell death (ICD) in melanoma cells through endoplasmic reticulum stress, while also inhibiting hypoxia-induced immune suppression [7] - The design of Ru/TiO₂ aims to reverse immune suppression and enhance immunogenicity, transforming "immune cold" tumors into "immune hot" tumors [7] Group 3: Clinical Implications - The findings suggest that the rational design of robust and efficient biocatalytic materials could extend beyond cancer treatment, opening new avenues for immune modulation in other diseases [3][6]

Core Viewpoint - The stock of Valiant Biosciences-B (09887) rose over 5% following the announcement of the first patient enrollment in a Phase Ib/II clinical trial for LBL-024, a dual-specific antibody targeting PD-L1/4-1BB for the treatment of advanced melanoma [1] Group 1: Company Developments - Valiant Biosciences announced the successful enrollment of the first patient in the Phase Ib/II clinical trial (NCT07099430) for LBL-024, which will explore its use as a monotherapy or in combination for first-line treatment of advanced melanoma [1] - LBL-024 is noted as the first targeted therapy for the 4-1BB receptor to reach the registration clinical stage globally, with potential to become the first approved drug for advanced pulmonary neuroendocrine carcinoma [1] Group 2: Market Reaction - Following the announcement, Valiant Biosciences' stock price increased by 4.84%, reaching 65 HKD, with a trading volume of 22.107 million HKD [1] Group 3: Research and Development Focus - CMB International previously released a report highlighting Valiant Biosciences' focus on developing immunotherapies involving immune checkpoint inhibitors and co-stimulatory agonists, while also expanding into other areas such as CD3 T cell connectors and antibody-drug conjugates (ADC) [1] - The company has developed proprietary platforms, LeadsBody and X-body, which serve as engines for continuous drug discovery [1] - The firm is optimistic about the development of PD-L1/4-1BB and TCE as next-generation immuno-oncology therapies [1]